Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program
Authors' conclusion
The BDP may qualify new, costly devices for higher and automatic Medicare reimbursement despite evidence not being representative of CMS beneficiaries and persistent uncertainty of benefit and risk.
Study context
- Population
- Cardiovascular devices with Food and Drug Administration (FDA) Breakthrough designation3 device examples
- Outcome
- Evidence standards and reimbursement for cardiovascular devices with FDA Breakthrough designation (3 device examples)
Methodological details3 cardiovascular device examples, publicly available information
- 3 cardiovascular device examples
- Publicly available information
Main finding
As reported in the abstract
Breakthrough designation allowed a decrease in enrollment of a trial supporting approval (1 case)
30%
Original publication
Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program. JAMA Cardiol. Published 1 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →